FDA Device recall Z-0870-2015
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating
- FDA Device
- Class II
- terminated
- Published 2014-12-31
On 2014-12-31 the FDA classified a Class II recall of Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating by Maquet Cardiovascular Us Sales, citing maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine C….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0870-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-11-05 |
| Published | 2014-12-31 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Maquet Cardiovascular Us Sales |
| Distribution | DC, MA, MI |
Product
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carbon dioxide and adjust blood temperature.
Reason
Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioliine Coating are labeled correctly with the Bioline coating, the individual cartons and 4-pack shipping containers of this lot incorrectly bear Softline coating labels instead of the bioline coating labels.
Identifiers
| code_info | k100278 Lot number 70100610 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0870-2015%22
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